A Prospective Study on the Incidence and Risk Factors Related to Infection in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,204
- 试验地点
- 24
- 主要终点
- The incidence of infection and type of infection in patients with ulcerative colitis and Crohn's disease, regardless of treatment received. ulcerative colitis and Crohn's disease, regardless of treatment received.
研究概览
简要总结
The purpose of this study is to determine the incidence and risk factors related to Infection in patients with Inflammatory Bowel Disease (IBD)
详细描述
IBD could lead to an increased risk of infections, particularly related to immunosuppressive therapy. The true effect of having IBD in the development of infections has not been studied in depth since the cohort studies are scarce and the results of studies with different approaches are contradictory.
The limited time period of former studies may not be enough to assess infectious complications that may occur in a long term period.
Moreover, certain polymorphisms demonstrated to confer a higher risk of opportunistic infections under immunosuppressive conditions, for instance HIV, patients with cystic fibrosis and Candida' infections. For this reason, it seems reasonable to think that genetic factors might play a role in the risk of opportunistic infections in IBD.
The hypothesis of this study is that patients with IBD have an increased risk of infection by immunosuppressive treatment.
TYPE OF STUDY Prospective cohort study that evaluates the effect of immunosuppression and other clinical factors in the onset of infection in IBD
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •HIV infection or any congenital immunodeficiency at the time of inclusion.
- •To be under any immunosuppressant therapy for another reason other than IBD at IBD diagnosis.
- •No consent to participate.
结局指标
主要结局
The incidence of infection and type of infection in patients with ulcerative colitis and Crohn's disease, regardless of treatment received. ulcerative colitis and Crohn's disease, regardless of treatment received.
时间窗: Change from baseline incidence and type of infection at 3 and 5 years
Serious infection means any untoward medical occurrence that at any dose: * Results in death or life-threatening * Requires in patient hospitalization or prolongation of an existing hospitalization * Is a medically important event. * Requires specific chemotherapy treatment * Emerges repeatedly. * Induces a switch or a withdrawal of the immunosuppressive or biological treatment
Clinical, demographic, epidemiologic and genetic factors associated with the risk of infection in patients with IBDassociated with the risk of infection in patients with IBD.
时间窗: Change from baseline and at 3 and 5 years
次要结局
- The type of infections in IBD patients grouped by systems and whether they are opportunistic or not.(at baseline and at 3 and 5 years)
- The effect of duration and immunosuppressive potency in the development of infections(at baseline and at 3 and 5 years)
- The impact of infection on morbidity and mortality in patients with IBD.(at baseline and at 3 and 5 years)